Ignite Creation Date:
2024-05-06 @ 12:54 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01680224
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2012-08-29
Brief Title:
Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Sponsor:
Oregon Research Institute
Organization:
Oregon Research Institute
Study Overview
Official Title:
Effectiveness Trial of a Dissonance-Based Obesity Prevention Program
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Project Health
Brief Summary:
Obesity is a major US public health problem Few obesity prevention programs have reduced risk for weight gain over follow-up and those that have are very intensive making dissemination difficult and costly A brief 3-hr selective prevention program Healthy Weight targeting young adults with body dissatisfaction involving participant-driven healthy dietary and physical activity lifestyle changes significantly reduced increases in body mass index BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up though effects were small in magnitude To enhance efficacy the investigators added dissonance-inducing activities regarding unhealthy dietary and activity practices drawing from a highly efficacious dissonance-based eating disorder prevention program A pilot trial found that this new Project Health intervention significantly reduced increases in BMI relative to both the Healthy Weight intervention and an educational brochure condition from pre to post The investigators propose to conduct a rigorous multisite effectiveness trial that will test whether adding the dissonance-induction elements to the originally Healthy Weight intervention improves weight gain prevention effects 360 college students at risk for future weight by virtue of their age and weight concerns will be randomized one of three conditions 1 a refined 6-hr group-based dissonance-based Project Health 2 a 6-hr group-based Healthy Weight intervention or 3 a psychoeducational video Weight of the World condition Participants will complete assessments of body fat mediators including objectively measured physical activity moderators and other outcomes at pre post and 6 12 and 24 month follow-ups
Detailed Description:
Aim 1 will test the hypothesis that Project Health significantly reduces increases in body fat relative to the Healthy Weight intervention and video control condition during a 2-yr follow-up secondary outcomes are BMI depressive symptoms and eating disorder symptoms The investigators will also compare Healthy Weight to video controls
Aim 2 will test the hypothesis that Project Health participants will experience increased cognitive dissonance an uncomfortable psychological state regarding eating unhealthy foods and engaging in sedentary behaviors and that changes in dissonance mediate the programs weight gain prevention effects The investigators will also test whether reduced calorie intake and increased physical activity mediate the effects of Project Health on change in body fat
Aim 3 will test the hypothesis that intervention effects are amplified for participants with elevated body dissatisfaction which should increase motivation change and preference for consistency which should maximize dissonance induction and mitigated for participants who report emotional eating and substance use because these factors increase risk for overeating
Aim 2 will test the hypothesis that Project Health participants will experience increased cognitive dissonance an uncomfortable psychological state regarding eating unhealthy foods and engaging in sedentary behaviors and that changes in dissonance mediate the programs weight gain prevention effects The investigators will also test whether reduced calorie intake and increased physical activity mediate the effects of Project Health on change in body fat
Aim 3 will test the hypothesis that intervention effects are amplified for participants with elevated body dissatisfaction which should increase motivation change and preference for consistency which should maximize dissonance induction and mitigated for participants who report emotional eating and substance use because these factors increase risk for overeating
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None